DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed April 27, 2026 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 16, 17, 19-26, 28-30, and 34-40 are pending.
Election/Restrictions
4. In the replies filed on January 22, 2024 and February 6, 2025, applicant elected Group I, now claims 16, 17, 19-26, 28-30, and vegetable nitrate source for species A and Beta vulgaris for species A-1 without traverse.
5. Claims 22, 34-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim.
6. Claims 16, 17, 19-21, 23-26, and 28-30 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claim(s) 16, 17, 19-21, 23-26, and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey (US 2016/0303177) in view of Malaguti (J. Appl. Physiol. (2009), vol. 107, pp. 1028-1036) with “Golden Beets, White Beets, and Red Beets” article (https://resyncproducts.com/blogs/resync-blog/golden-beets-white-beets-and-red-beets#:~:text=Different%20betalains%20create%20different%20colors,is%20the%20antioxidant%20%E2%80%9Cbetaine%E2%80%9D ) providing evidence in regards to beet characteristics for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
First, Applicant respectfully submits that the Examiner's conclusion of obviousness is
based on improper hindsight reasoning…Bailey purports to disclose nutritional supplements that comprise any two or more of "thirteen unique components" (Bailey, I [0026]): L-citrulline, pine bark extract, beetroot, beta alanine, L-carnitine, branched chain amino acids, coenzyme Q10, green tea extract, glycerylphosphorylcholine, tart cherry extract, D-ribose, Rhodiola rosea, and shisandra berry (id., 1 [0008]). The Examiner, relying on Applicant's disclosure as a roadmap, has selectively identified beetroot (a "vegetable nitrate source") and green tea extract (which comprises
caffeine) and alleged that Bailey teaches that supplements comprising these two specific
ingredients "enhance[e] muscle recovery after athletic performance [and are] useful in increasing energy and promoting cognition." Office Action of October 27, 2025, p. 3. But of the eight specific formulations disclosed by Bailey, only three (Formulations 1, 7, and 8) include both beetroot and green tea extract. Each of these three formulations includes multiple others of the "thirteen unique components" mentioned by Bailey (nine others in Formulation 1, six others in Formulation 7, and all eleven others in Formulation 8), and the Examiner has not articulated any reason why a person of ordinary skill in the art would, at the time of filing of the present application, have selected these two specific ingredients mentioned by Bailey and combined them with sulforaphane in a composition to "promote[] concentration, ha[ve] a stimulating effect, and/or lower arterial blood pressure," as present independent claim 16 recites. In the absence of any such reasoning, it must be concluded that the Examiner has used Applicant's own invention as a "roadmap" to "selectively cull[]" individual components from the formulations of
Bailey and allege that their combination with the sulforaphane taught by Malaguti would be obvious; as explained above, obviousness rejections based on this approach are improper as a matter of law.
Second, Bailey, as the Examiner has interpreted it, does not set forth a finite number of
identified, predictable solutions. An "obvious to try" line of reasoning may properly support an obviousness rejection if "there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions." KSR International Co. V. Teleflex Inc., 550 U.S. 398, 421 (2007) (emphasis added); see also MPEP 2144(II)(B). Under the Examiner's interpretation, the teachings of Bailey encompass at least 2¹³ - 14 = 8,178 distinct formulations. Bailey also provides very limited teachings as to which of these formulations would "promote[] concentration, ha[ve] a stimulating effect, and/or lower arterial blood pressure," as present independent claim 16 recites, and to the extent any such teachings are present, they teach that
these benefits are achieved by ingredients other than beetroot and/or green tea extract. 2 Thus, Each of Bailey's "thirteen unique components" is either present or absent, and Bailey teaches that its supplements must include "two or more" of these components, thus excluding one formulation in which zero of the thirteen are present and thirteen formulations in which exactly one of the thirteen is present. Bailey, 1 [0008]. Bailey does not provide any teachings as to formulations that promote concentration. The only one of the "thirteen unique components" that Bailey teaches may serve as a stimulant is shisandra berry, and the only two that it teaches may lower blood pressure are L-citrulline and shisandra berry. Bailey, 11 [0027], [0034]. Bailey's teachings, as the Examiner has interpreted them, set forth a very large number of possible solutions and do not allow the person of ordinary skill in the art to predict which of these compositions may be effective for the purposes of the present invention.
Third, the Examiner has not demonstrated that beetroot alone can achieve the benefits of
the presently claimed invention. Without being bound by theory, the present inventors have hypothesized that the vegetable nitrate source in compositions according to independent claim 16 is effective as an antihypertensive agent "based
on the NO metabolism, which leads to the reduction of nitrate (NO₃) via nitrite (NO₂) to nitrogen monoxide (NO)." Present specification as published, 1 [0039]. Bailey nowhere teaches that beetroot alone has a sufficient effect on nitrate metabolism to achieve this effect to any significant extent, and all of the specific compositions disclosed by Bailey that include beetroot (Formulations 1, 7, and 8) also include other ingredients, particularly L-citrulline and pine bark extract, that can also influence nitrate
metabolism. Thus, to whatever extent any of the compositions taught by Bailey would
"promote[] concentration, ha[ve] a stimulating effect, and/or lower arterial blood pressure," as present independent claim 16 recites, the person of ordinary skill in the art would not have had any reason to conclude that these effects are due to the inclusion of beetroot (or green tea extract) rather than other components included in these compositions.
However, applicant’s claims use the broad transitional phrase “comprising.” As discussed in MPEP section 2111.03, “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps…”. Thus, the additional ingredients required in the compositions of Bailey are not excluded from applicant’s claims. No “picking and choosing” is required, the artisan would be motivated to use the entire composition taught by Bailey, i.e. compositions that comprise beet root and green tea, for the purposes taught by Bailey. In addition, the fact that Bailey does use the composition for the same purpose is not considered to render the claims allowable over the prior art. Applicant’s claims are drawn to composition claims with an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The references together teach a composition with the same ingredients as claimed in the same amounts as claimed. If the reference composition is not capable for performing the claimed intended use, then applicant’s invention arguably does not function as claimed. In addition, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant also argues:
Fourth, the person of ordinary skill in the art, considering the teachings of Bailey, would
not have been motivated to add sulforaphane as taught by Malaguti to any of Bailey's
compositions. The Federal Circuit has established a two-part inquiry for assessing obviousness of chemical compositions: (1) "determine[] whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts," and (2) if so, assess "whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success." Otsuka Pharmaceutical Co., Ltd. V. Sandoz, Inc., 678 F.3d 1280, 1291-92 (Fed. Cir. 2012). The Examiner alleges that a person of ordinary skill in the art would have found it obvious to add sulforaphane to a composition taught by Bailey to "protect[] muscle during exercise" because "Malaguti teaches that sulforaphane is useful for protecting against muscle damage caused by exercise." Office Action of October 27, 2025, pp. 3-4 (citing Malaguti, Abstract). But Bailey itself specifically teaches that at least three
of its eleven "unique components" other than beetroot and green tea extract-namely coenzyme Q10, L-carnitine, and Rhodiola rosea-are effective to protect against muscle damage. Bailey, 11 [0031], [0032], [0035]. The person of ordinary skill in the art would therefore not have had any reason or motivation to add sulforaphane as taught by Malaguti to any of Bailey's compositions; instead, such a person would simply have used any one or more of the at least three ingredients taught by Bailey to achieve the benefit alleged by the Examiner.
However, as discussed in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 421, 82 USPQ2d 1385 (2007):
A person of ordinary skill in the art is also a person of ordinary creativity, and not an automaton…When there is a design need of market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
It is well established that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. Thus, an artisan being a person of ordinary creativity would be motivated to add sulforaphane to the composition of Bailey based on their known shared use. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
In addition, applicant argues:
Fifth, Bailey teaches away from the vegetable nitrate source : caffeine ratio range recited
by present independent claim 16. Bailey explicitly provides that "[f]or each of the exemplary formulations shown in FIGS. 1-7, the amount of each component in one dose is the same as that listed in FIG. 9." Bailey, 1 [0041] (emphasis added). Figure 9 of Bailey shows a beetroot content per dose of 6 g - 9 g and a green tea extract content per dose of 250 mg - 375 mg. Bailey nowhere discloses any source of caffeine in any of its formulations other than green tea extract, and specifically notes that the "special formula" for green tea extract used in its formulations contains "about 50% caffeine." Id., I [0040]. Thus, Bailey specifically teaches that, on a per-dose basis, all of its formulations that contain both beetroot and green tea extract contain at least 6 g of beetroot and no more than 375 mg * 50% = 187.5 mg of caffeine, and therefore the smallest possible ratio of beetroot to caffeine in any composition disclosed by Bailey (where both are present) is 6 g : 187.5 mg, or 32:1-far in excess of the maximum value of 20:1 for the vegetable
nitrate source : caffeine ratio recited by present independent claim 16.
However, Bailey states that the dosage in Figure 9 are only exemplary (see paragraph 40). Bailey also gives additional examples of useful dosages as 500 mg of nitrate and 125 mg of caffeine (see paragraphs 38 and 40). These dosages fall within the broad range of ratios claimed in claim 16 and the broad range of dosages set forth in claims 17 and 23. Thus, applicant’s argument is not persuasive.
8. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
